Monoclonal antibody stopped in ACTIV-3 study: bamlanivimab shows lack of benefit in people hospitalised with COVID-19
11 November 2020. Related: COVID-19: investigational drugs, COVID-19.
Simon Collins, HIV i-BaseOn 26 October 2020, a press statement from Eli Lilly reported that it had stopped further recruitment of the monoclonal antibody bamlanivimab (LY3819253) into a study of people hospitalised with COVID-19. [1, 2]
A press release issued by the US NIAID who sponsor the ACTIV-3 study included more details – and although this compound has been stopped, the ACTIV-3 study will continue. [3]
This study is designed to investigate promising compounds as treatment for late-stage COVID-19. All participants receive standard of care that includes remdesivir.
The decision to stop bamlanivimab followed a predefined efficacy review by the Data and Safety Monitoring Board (DSMB) on the first 300 participants (stage 1), based on clinical benefits after five days on an ordinal scale. Recruiting a further 700 participants only occurs (stage 2) depends on seeing an early signal of efficacy.
The DSMB review showed that bamlanivimab was “unlikely to help” people with hospitalised COVID-19 “recover from this advanced stage of their disease”. There were no significant safety issues.
No further details have been released yet on the study or these early results.
Other studies with bamlanivimab, in different populations, are continuing. These include:
- ACTIV-2 in people recently diagnosed in mild to moderate COVID-19, also sponsored by the US NIH (also overseen by the same DSMB). [4]
- BLAZE-1, an ongoing phase 2 trial in people recently diagnosed with earlier stage non-hospitalised COVID-19, also in combination with etesevimab. Interim results were just published in NEJM. [5, 6]
- BLAZE-2, an ongoing phase 3 study of bamlanivimab as prophylaxis in residents and staff living in care facilities. [7]
comment
Although the results are disappointing the study itself shows the importance of being able to rapidly identify likely futility with this particular monoclonal antibody.
The ACTIV-3 study is an adaptive platform study that is designed to study multiple investigational compounds compared to placebo and further drugs are due to be added shortly.
References
- Lilly statement regarding NIH’s ACTIV-3 clinical trial.
https://www.lilly.com/news/stories/statement-activ3-clinical-trial-nih-covid19 - ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO).
https://clinicaltrials.gov/ct2/show/NCT04501978 - NIH Statement. NIH-sponsored ACTIV-3 trial closes LY-cov555 sub-study. (26 October 2020).
https://www.niaid.nih.gov/news-events/statement-nih-sponsored-activ-3-trial-closes-ly-cov555-sub-study - ACTIV-2: A study for outpatients with COVID-19.
https://clinicaltrials.gov/ct2/show/NCT04518410 - A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness.
https://clinicaltrials.gov/ct2/show/NCT04427501 - Chen P. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. NEJM, DOI: 10.1056/NEJMoa2029849. (28 October 2020).
https://www.nejm.org/doi/full/10.1056/NEJMoa2029849 - A Study of LY3819253 (LY-CoV555) in preventing SARS-CoV-2 infection and COVID-19 in nursing home residents and staff.
https://clinicaltrials.gov/ct2/show/NCT04497987
This report was first posted on 28 October 2020.